Status:
COMPLETED
A Long-Term Monitoring Study of the IMT-002 Patients
Lead Sponsor:
VisionCare, Inc.
Conditions:
Macular Degeneration
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
This is a 5-year study of patients implanted with the Implantable Miniature Telescope (IMT by Dr. Isaac Lipshitz) under Protocol IMT-002. All patients implanted with the telescope prosthesis who enrol...
Detailed Description
Every 6 months, manifest refraction, visual acuity, intraocular pressure, slit lamp examination, endothelial cell density, device failures, complications and adverse events will be assessed.
Eligibility Criteria
Inclusion
- Patients must have participated in the IMT-002 trial.
- Patients must be able to understand and comply with the requirements of the clinical study, and be able to abide by the requirements and restrictions of the study.
- Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.
Exclusion
- Patients who have not participated in the IMT-002 trial.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00976235
Start Date
June 1 2006
End Date
May 1 2011
Last Update
November 6 2017
Active Locations (28)
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1
Retina Centers P.C.
Tucson, Arizona, United States, 85704
2
University of California at Irvine
Irvine, California, United States, 92697
3
Altos Eye Physician
Los Altos, California, United States, 94024
4
Doheny Retina Institute - University of Southern California
Los Angeles, California, United States, 90033